Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004497
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension
Sponsor:
United Therapeutics
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension
I Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to center and etiology of disease
Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks
After completing 12 weeks of treatment patients may continue therapy with open label UT-15 Patients who received placebo cross over to receive UT-15
Completion date provided represents the completion date of the grant per OOPD records
Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks
After completing 12 weeks of treatment patients may continue therapy with open label UT-15 Patients who received placebo cross over to receive UT-15
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTC-P01-04 | None | None | None |
| UTC-FDR001545 | None | None | None |